MyelofibrosisPhase 1RopeRuxNCT07521046
Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis
A Phase 1 study testing ropeginterferon alfa- 2b and Ruxolitinib in people with Myelofibrosis, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- ropeginterferon alfa- 2b and Ruxolitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2026to Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged ≥ 18 years.
- Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.
- Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.
- Note: Conversion between immediate -released (IR) ruxolitinib to an equivalent dose of extended -release (XR) ruxolitinib should not be considered a dose change.
- Subjects must have spleen volume of > 450ml by either MRI or CT scan
- Subject must have a JAK2, CALR, or MPL allelic burden of ≥20% at screening
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- --Prior treatment for PV or ET with hydroxyurea or ruxolitinib is allowed. If the patient was on pegylated interferon in the past, the progression from PV/ ET to post-PV/ET MF must not have occurred while on pegylated interferon therapy.
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined as:
- --Hematologic:
- ---WBC count ≥ 4 x 109/L
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 8 g/dL
- --Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- --Renal:
- Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
- Recovery to baseline or ≤ Grade 1 CTCAE v 6.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
- Participants must adhere to the following sex and contraceptive/barrier requirements:
- If participant is of childbearing potential, they must have a negative pregnancy test
- For participants of non-childbearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- < 50 years of age:
- ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- --≥ 50 years of age:
- ---Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- ---Had radiation-induced menopause with last menses >1 year ago; or
- ---Had chemotherapy-induced menopause with last menses >1 year ago
- ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 6.4.1 and 6.4.3.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.
- Receiving other investigational agents.
- Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).
- Evidence of severe retinopathy or clinically significant eye disease.
- History or presence of active serious or untreated autoimmune disease.
- History of solid organ transplant.
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- Liver cirrhosis Child-Pugh score B or C.
- 5% blasts in peripheral blood or bone marrow.
- Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
- Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
- The diagnosis of another malignancy which, in the investigator's opinion, is likely to significantly impact study participation.
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Uncontrolled hypertension, in the opinion of the investigator
- Congestive heart failure New York Heart Association Class II or greater, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke or myocardial infarction within the past 3 months
- Significant coronary stenosis, in the opinion of the investigator
- QTc prolongation defined as a QTcF > 500 ms.
- Known congenital long QT.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- -Active infection requiring systemic therapy, including, but not limited to: tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
- Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v 6.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 7.8. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Nicole Fisher, 801-587-7604, nicole.fisher@hci.utah.edu
About this study
Official title: A Phase 1b Study of Safety, Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.
- Conditions
- Myelofibrosis
- Being tested
- ropeginterferon alfa- 2b, Ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropeginterferon alfa- 2bDrug
Ropeginterferon alfa- 2b will be administered as a subcutaneous injection every two weeks.
RuxolitinibDrug
Ruxolitinib will be administered per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: All Patients | Experimental | This study will investigate the safety and tolerability of ropeginterferon alfa- 2b added on to standard of care ruxolitinib. Receives: Drug: ropeginterferon alfa- 2b; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment.
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Measured: 2 years
Secondary outcomes (6)
The proportion of subjects who achieve >50% reduction in JAK2 V617F mutation burden.
To assess the incidence of patients who achieve >50% reduction in JAK2 V617F mutation burden.
Measured: 2 years
Change in JAK2, CALR, MPL mutations allelic burden.
To assess the rate of reduction of JAK2, CALR, MPL mutations allelic burden.
Measured: 2 years
The proportion of subjects who achieve a 25% decrease in spleen volume by 24 weeks from initiation of combination treatment.
To assess the rate of 25% spleen volume reduction at 24 weeks of the combination (Abdominal MRI will be done for spleen size measurement).
Measured: 24 weeks
Change in quality of life Myeloproliferative Neoplasm (MPN) Symptom Questionnaire from baseline and throughout treatment.
To assess the change in the quality of life MPN Symptom Questionnaire score. The MPN Symptom questionnaire consists of 10 questions asking patients to rate their symptoms on a scale of 1 to 10, with 0 being no symptoms and 10 being the worst symptoms.
Measured: 2 years
The proportion of subjects who progress to blastic phase and secondary acute myeloid leukemia at 2 years post-treatment.
To assess the rate of blastic transformation.
Measured: 2 years
The proportion of subjects who have a change in bone marrow fibrosis grade.
To assess the rate of change in myelofibrosis (MF) grade (MF grade 0 to 3, the higher the worse).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start21 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Tsewang Tashi, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521046
- Sponsor's protocol ID
- 171996
- Acronym
- RopeRux
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Safety, Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
- ClinicalTrials.gov ID
- NCT07521046
- Acronym / sponsor ID
- RopeRux / 171996
- Conditions
- Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- PharmaEssentia
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: All Patients | Experimental | Drug: ropeginterferon alfa- 2b, Drug: RuxolitinibThis study will investigate the safety and tolerability of ropeginterferon alfa- 2b added on to standard of care ruxolitinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Male or female subject aged ≥ 18 years.
- Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.
- Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.
- Note: Conversion between immediate -released (IR) ruxolitinib to an equivalent dose of extended -release (XR) ruxolitinib should not be considered a dose change.
- Subjects must have spleen volume of > 450ml by either MRI or CT scan
Key exclusion criteria (27 listed)
- PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.
- Receiving other investigational agents.
- Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).
- Evidence of severe retinopathy or clinically significant eye disease.
- History or presence of active serious or untreated autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropeginterferon alfa- 2bRopeginterferon alfa- 2b will be administered as a subcutaneous injection every two weeks. | Drug | Treatment: All Patients |
| RuxolitinibRuxolitinib will be administered per standard of care. | Drug | Treatment: All Patients |
Primary outcome
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type
Time frame: 2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).
Time frame: 2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Time frame: 2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Time frame: 2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment.
Time frame: 2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
6 secondary outcomes
The proportion of subjects who achieve >50% reduction in JAK2 V617F mutation burden.
Time frame: 2 years
Change in JAK2, CALR, MPL mutations allelic burden.
Time frame: 2 years
The proportion of subjects who achieve a 25% decrease in spleen volume by 24 weeks from initiation of combination treatment.
Time frame: 24 weeks
Change in quality of life Myeloproliferative Neoplasm (MPN) Symptom Questionnaire from baseline and throughout treatment.
Time frame: 2 years
The proportion of subjects who progress to blastic phase and secondary acute myeloid leukemia at 2 years post-treatment.
Time frame: 2 years
The proportion of subjects who have a change in bone marrow fibrosis grade.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
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Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
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Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsewang Tashi, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ropeginterferon alfa- 2b and Ruxolitinib in people with Myelofibrosis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Fisher (801-587-7604, nicole.fisher@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.